Medline Industries Recalls Surgical Convenience Kits Over Sterility Concerns
Medline Industries, LP is recalling 4,415 units of various surgical convenience kits due to equipment calibration issues that may compromise the sterility of the medical devices.
What Happened
Medline Industries, LP has initiated a voluntary Class II recall for several types of Medline Convenience Kits. The recall was prompted by the identification of calibration issues with the equipment used to sterilize and package the devices. Although the products were exposed to validated sterilization cycles, the calibration errors have the potential to impact the sterility assurance level (SAL) of the kits.
Which Products Are Affected
The recall affects approximately 4,415 units distributed nationwide in the U.S. and worldwide. Affected products include 36 different model types, such as:
- Hysteroscopy Kits: Models CDS984086I, DYNJ903327K, DYNJ51741B, DYNJ59444G, DYNJ903327K
- Vaginal Hysterectomy Packs: Models DYNJ0373807J, DYNJ0373807K, DYNJ31344J, DYNJ31344K, DYNJ33393L, DYNJ33393M, DYNJ33393N, DYNJ33393O, DYNJ67161
- Robotic Hysterectomy Packs: Models DYNJ69713B, DYNJ69713C, DYNJ903798G
- LAVH Packs and Totes: Models DYNJ36712F, DYNJ58121C, DYNJ908340, DYNJ908340A, DYNJ908340B, DYNJ908340D, DYNJ910537, DYNJV0312G
- Other Specialized Kits: GYN Oncology Lap (DYKMBNDL91A), Minor Vaginal #76-RF (DYNJ27434R), D&C Minor Lithotomy (DYNJ45090I), D&C Hysteroscopy (DYNJ45801C), Vaginal Hysterectomy Pack-LF (DYNJ47694I), GYN-Minor-Litho (DYNJ59037B), D&C Pack (DYNJ61282B), Peri GYN (DYNJ67708A), Anorectal Pack (DYNJ83560), D&C CDS (DYNJ902560I), TLH Kit (DYNJ908149), and Vag Hyst Pack (DYNJT3348).
Specific lot numbers and UDI-DI information are associated with each model. The recall is tracked under FDA recall number Z-1418-2026.
What You Should Do
Medline Industries notified customers via letter starting January 7, 2026. Healthcare facilities and distributors should immediately check their inventory for the affected model and lot numbers. Affected products should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information regarding returns or instructions, facilities should contact Medline Industries, LP at their Northfield, IL headquarters.
Why This Matters
The use of medical devices with compromised sterility poses a risk of post-operative infections and other complications for patients. Ensuring the integrity of the sterilization process is critical for maintaining patient safety during surgical procedures.
Source
This information is based on official recall data provided by the FDA.
Source: FDA Official Notice